BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI 5

    MDR report key: 25319594 · Received May 28, 2026

    Report

    Report Number
    2955842-2026-26268
    Event Type
    Malfunction
    Date Received
    May 28, 2026
    Date of Event
    May 6, 2026
    Report Date
    May 28, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119716
    PMA / PMN Number
    K232610
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. BASED ON THE FIELD EVALUATION, THIS REPORTED EVENT WAS NOT CONFIRMED. FSE WAS UNABLE TO REPLICATE THE REPORTED ISSUE. FSE LOOKED AT LOGS, AND ERROR 100 HAD OCCURRED ON DIFFERENT ARMS IN THE PAST. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY SURGICAL PROCEDURE, UNIVERSAL SURGICAL MANIPULATOR (USM) 4 CAME UNCLUTCHED IN THE MIDDLE OF THE PROCEDURE. NO ONE WAS NEAR THE USM WHEN IT CAME FREE AND MOVED ON ITS OWN. THE CALLER WAS NOT ABLE TO CAPTURE AN IMAGE OF THE ERROR CODE BEFORE ANOTHER STAFF MEMBER CLEARED IT. TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE LOGS AND SAW ERROR 100 FOR SET UP JOINT (SUJ) MOVED WITHOUT BEING CLUTCHED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164382 DAVINCI 5 PATIENT SIDE CART NAY INTUITIVE SURGICAL, INC 380747-41 N/A 00886874119716

    Patients

    Seq Age Sex Outcome Treatment
    1